BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROTAINER® CONTACT-ACTIVATED LANCET

    MDR report key: 23310660 · Received October 16, 2025

    Report

    Report Number
    2243072-2025-01258
    Event Type
    Malfunction
    Date Received
    October 16, 2025
    Date of Event
    September 17, 2025
    Report Date
    November 21, 2025
    Manufacturer
    BECTON DICKINSON & CO (FRANKLIN LAKES)
    Product Code
    FMK
    UDI-DI
    30382903665946
    PMA / PMN Number
    K223243
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND NO ISSUES WERE OBSERVED RELATING TO BREAKS OFF DURING USE AS ALL SAMPLES MET SPECIFICATIONS. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE BREAKS OFF DURING USE. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER PHONE #: (B)(6). THE MANUFACTURING LOCATION FOR THIS PRODUCT IS HTL. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING ONE (1) BD MICROTAINER® CONTACT-ACTIVATED LANCET, THE BLADE BROKE OFF IN THE CUSTOMER'S FINGER AND WAS REMOVED USING TWEEZERS. NO MEDICAL INVENTION WAS REPORTED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING ONE (1) BD MICROTAINER® CONTACT-ACTIVATED LANCET, THE BLADE BROKE OFF IN THE CUSTOMER'S FINGER AND WAS REMOVED USING TWEEZERS. NO MEDICAL INVENTION WAS REPORTED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2550070 BD MICROTAINER® CONTACT-ACTIVATED LANCET MANUAL SURGICAL INSTRUMENT FOR GENERAL USE FMK BECTON DICKINSON & CO (FRANKLIN LAKES) E7C78C9 30382903665946

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown